FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLANMECA SOVEREIGN
K Number: K081699
·
Decision Aug 29, 2008
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
13
Review Days
73
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Basic Information
- Device Name
- PLANMECA SOVEREIGN
- K Number
- K081699
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Planmeca USA, Inc.
- Date Received
- June 17, 2008
- Decision Date
- August 29, 2008
- Product Code
- EIA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Planmeca USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111361 | PLANMED NUANCE EXCEL | Sep 23, 2011 | Substantially Equivalent |
| K923534 | PM2002 PROLINE | Jan 31, 1994 | Substantially Equivalent |
| K923533 | ADMARK | Mar 4, 1993 | Substantially Equivalent |
| K923462 | DELIGHT | Dec 21, 1992 | Substantially Equivalent |
| K923461 | PM2002 PROLINE, PM2002 PROLINE EC | Dec 21, 1992 | Substantially Equivalent |
| K904953 | PLANMED SOPHIE | Apr 18, 1991 | Substantially Equivalent |
| K904947 | PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE | Jan 30, 1991 | Substantially Equivalent |
| K904948 | PM2002 CC AND PM2002 EC | Jan 30, 1991 | Substantially Equivalent |
| K864474 | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC | Nov 26, 1986 | Substantially Equivalent |
| K842359 | AUTOMATIC PATIENT CHAIR PM2000 & A | Sep 19, 1984 | Substantially Equivalent |